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chugai pharmaceutical co ltd (4519) Details

Chugai Pharmaceutical Co., Ltd., together with its subsidiaries, engages in the research and development, manufacture, marketing, and distribution of prescription medicines in Japan, Switzerland, and internationally. Its products for oncology include Avastin, Rituxan, Herceptin, Perjeta, Kadcyla, Xeloda, Tarceva, Neutrogin, Alecensa, Zelboraf, Aloxi, and Akynzeo; bone and joint diseases/autoimmune diseases comprise Alfarol, Edirol, Bonviva, Actemra, and Suvenyl; renal diseases consist of Mircera, Epogin, and Oxarol; and transplant, immunology, infectious, and other diseases comprise Tamiflu, CellCept, Pegasys, Copegus, and Sigmart. The company also has various products under development in the areas of oncology, bone and joint diseases, autoimmune diseases, central nervous system, and other diseases. The company has strategic alliances with Roche Group and Genentech; and co-development agreements with Taisho Pharmaceutical Co., Ltd. and Nippon Shinyaku Co., Ltd. The company was founded in 1925 and is headquartered in Tokyo, Japan. Chugai Pharmaceutical Co., Ltd. is a subsidiary of Roche Holding Ltd.

chugai pharmaceutical co ltd (4519) Key Developments

Chugai Pharmaceutical Co. Ltd. Reports Consolidated Earnings Results for the Nine Months Ended September 30, 2016; Provides Earnings Guidance for the Year Ending December 31, 2016; Provides Dividend Guidance for the Year Ending December 31, 2016; Announces Dividend for the Second Quarter of 2016

Oct 25 16

Chugai Pharmaceutical Co. Ltd. reported consolidated earnings results for the nine months ended September 30, 2016. For the period, the company reported revenues of ¥361,517 million against ¥367,772 million a year ago. Operating profit was ¥58,635 million against ¥67,059 million a year ago. Profit before taxes was ¥59,059 million against ¥67,390 million a year ago. Net income was ¥43,702 million against ¥48,584 million a year ago. Net income attributable to company shareholders was ¥43,084 million against ¥47,647 million a year ago. Earnings per share diluted were ¥78.77 against ¥87.15 per share a year ago. Cash flows from operating activities was ¥43.8 million against ¥65.9 million a year ago. Purchase of property, plant and equipment was ¥27,419 million against ¥15,470 million a year ago. Purchase of intangible assets was ¥4,838 million against ¥5,868 million a year ago.
For the second quarter, the company announced dividend of ¥26.00 per share against ¥26.00 per share a year ago.
For the year ending December 31, 2016, the company expects to pay dividend of ¥26.00 per share against ¥32.00 per share a year ago.
For the year ending December 31, 2016, the company expects revenues of ¥495,000 million, core operating profit of ¥71,000 million, core earnings per share of ¥92.54.

Chugai Pharmaceutical Co. Ltd. announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ACTEMRA®/RoACTEMRA® (tocilizumab), a Chugai originated drug, which is currently under development by Roche and Genentech for the indication of Giant Cell Arteritis (GCA). This designation was based on the GiACTA study, which is a global Phase III study assessing the efficacy and safety in patients with GCA. This is the fifth Breakthrough Therapy Designation for a Chugai originated drug, following these three products: alectinib (ALK-positive non-small cell lung cancer with disease progression on crizotinib, first line treatment for ALK-positive non-small cell lung cancer), tocilizumab (systemic sclerosis), and emicizumab (prophylactic treatment for patients 12 years or older with hemophilia A with factor VIII inhibitors). Based on Chugai’s business philosophy 'innovation all for the patients,' Chugai will collaborate with Roche and Genentech to submit marketing applications for ACTEMRA/RoACTEMRA in a number of countries around the world, with the intent to increase access to this new treatment option for patients and healthcare professionals as soon as possible. The Breakthrough Therapy Designation was adopted as part of the FDA Safety and Innovation Act (FDASIA) enacted in July 2012 aiming at expediting the development and review of drugs for the treatment of severe or life-threatening diseases or symptoms. In order to grant Breakthrough Therapy Designation, preliminary clinical evidence is required demonstrating that the drug may have substantial improvement on at least one clinically significant endpoint over existing therapies. Breakthrough Therapy Designation includes the features of a Fast Track designation, with the addition of intensive guidance on efficient drug development as well organizational commitment from FDA. Giant Cell Arteritis (GCA) belongs to an autoimmune disease called large-vessel vasculitis. GCA is a granulomatous vasculitis occurring primarily in the aorta and aortic branches, mainly the temporal arteries. Common initial symptoms include headache, systemic conditions such as fever, and loss of vision. GCA is prevalent in Western countries and affects women more than men with the typical age of onset 50 years or older. Vasculitis can be classified into three different groups depending on the size of the inflammatory vessels, such as large vessel vasculitis, medium vessel vasculitis and small vessel vasculitis. Besides GCA, Takayasu’s arteritis which appears more commonly in Asian young ladies is also included in large-vessel vasculitis. GiACTA (NCT01791153) is a Phase III, global, randomised, double-blind, placebo-controlled trial investigating the efficacy and safety of ACTEMRA®/RoACTEMRA® as a novel treatment for GCA. It is large clinical trial ever conducted in GCA and the first to use blinded, variable-dose, variable-duration steroid regimens. The multicenter study was conducted in 251 patients across 76 sites in 14 countries. The study's primary endpoint was the proportion of patients achieving sustained disease remission at week 52. The secondary endpoints were the time to first GCA flare after clinical remission, cumulative corticosteroid dose at week 52, and also safety outcome measures. The GiACTA data will be submitted for presentation at an upcoming medical conference and to regulatory authorities around the world for approval consideration.

Chugai Pharmaceutical Co. Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the first-line treatment of ALK positive non-small cell lung cancer (NSCLC) to Alecensa®, a highly selective ALK inhibitor created by Chugai. Alecensa® is approved in Japan and in the United States, and filed in Europe by Roche. This designation is based on the J-ALEX study, conducted by Chugai, which is an open-label, randomized phase III study that compares the efficacy and safety between Alecensa and crizotinib. The J-ALEX study enrolled 207 ALK-inhibitor naïve patients with ALK fusion gene positive advanced or recurrent NSCLC, who had not undergone chemotherapy or had undergone one chemotherapy regimen. The subjects were allocated to either the Alecensa arm or the crizotinib arm in a one to one ratio. The primary endpoint of the J-ALEX study was progression free survival (PFS) as assessed by a blinded independent review board. The secondary endpoints included overall survival, objective response rate and safety. In February 2016, an independent data monitoring committee recommended to discontinue the J-ALEX study early for benefit based on the results of the predetermined interim analysis which was examined by the committee. The PFS hazard ratio of the Alecensa arm to the crizotinib arm was 0.34, and Alecensa demonstrated significantly prolonged PFS (99.6826% CI: 0.17-0.70, stratified log-rank p<0.0001). Median PFS was not reached (95% CI: 20.3-Not reached) in the Alecensa arm while it was 10.2 months (95% CI: 8.2-12.0) in the crizotinib arm. In the Alecensa arm, constipation was an adverse event (AE) with >30% frequency, while in the crizotinib arm nausea, diarrhea, vomiting, visual disturbance, dysgeusia, constipation, ALT elevation and AST elevation were observed in >30% patients. Grade 3-4 AEs occurred in 27% of the Alecensa arm and in 51% of the crizotinib arm, with no treatment-related deaths in both arms.

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